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Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis

Primary Purpose

Postoperative Nausea and Vomiting

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Postoperative nausea and vomiting (PONV) reminder
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Procedure with General Anesthesia

Exclusion Criteria:

  • Postoperative admission to the Intensive Care Unit
  • Postoperative fast-track to Phase II
  • Patient remains sedated/intubated at the end of the procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PONV Reminder

    No PONV Reminder

    Arm Description

    After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display

    After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative nausea and vomiting
    Incidence of postoperative nausea and vomiting in the recovery room

    Secondary Outcome Measures

    Duration of postoperative anesthesia care unit (PACU) stay
    Time to postoperative anesthesia care unit (PACU) discharge alive (hours)

    Full Information

    First Posted
    October 5, 2015
    Last Updated
    August 10, 2017
    Sponsor
    The Cleveland Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02830412
    Brief Title
    Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis
    Official Title
    A Prospective Randomized Evaluation of an Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis Guideline Adherence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patients enrolled
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Cleveland Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project intends to develop and implement an electronic reminder for post-operative nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System. Each patient will have his or her PONV risk classified based on the following risk factors: Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of procedure > 60 minutes. Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning of the case. At the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines. If the current status is compatible or exceeds the recommended status the reminder will silently document compliance. If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence. The reminder will not recommend a specific medication, intervention or therapy. It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient. Subjects randomized to not receive the electronic display will have it deactivated.
    Detailed Description
    Each patient will have his or her PONV risk classified based on the following risk factors Female gender, History of PONV or Motion Sickness, Non-smoker and Duration of procedure > 60 min utilizing information already entered into the Anesthesia Record Keeping System. Patients having 0-1 risks factors present will be low risk. 2 risks factors present are medium risk and more than 2 risk factors present are high risk. Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis will be displayed on the ARKS screen at the beginning of the case. In a second step at the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines. If the current status is compatible or exceeds the recommended status the reminder will silently document compliance. If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence. The reminder will display the PONV risk assessment information, current status of PONV prophylaxis as well as the information that current guidelines recommend additional PONV prophylaxis. The reminder will not recommend a specific medication, intervention or therapy. It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient. Subjects randomized to not receive the electronic display will have it deactivated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PONV Reminder
    Arm Type
    Experimental
    Arm Description
    After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display
    Arm Title
    No PONV Reminder
    Arm Type
    No Intervention
    Arm Description
    After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display
    Intervention Type
    Other
    Intervention Name(s)
    Postoperative nausea and vomiting (PONV) reminder
    Intervention Description
    The postoperative nausea and vomiting (PONV) electronic reminder will be programmed to assess the patient risk for PONV according to the risk factors identified by Apfel and Koivuranta. The PONV risk assessment and current guidelines will be displayed electronically for patients randomized to receive the reminder.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative nausea and vomiting
    Description
    Incidence of postoperative nausea and vomiting in the recovery room
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    Duration of postoperative anesthesia care unit (PACU) stay
    Description
    Time to postoperative anesthesia care unit (PACU) discharge alive (hours)
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Procedure with General Anesthesia Exclusion Criteria: Postoperative admission to the Intensive Care Unit Postoperative fast-track to Phase II Patient remains sedated/intubated at the end of the procedure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saager leif, M.D.
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis

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